Kornimate/medical-research-clean huggingface dataset:
post-market study to obtain surgeon feedback on clinical outcome in eyes implanted with tecnis toric ii iol

Conditions: Cataract; Corneal Astigmatism

Summary: this is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available tecnis toric ii, model zcu iol. the study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 us study sites.


Eligibility criteria:
inclusion criteria: 1. unilateral or bilateral cataracts for which phacoemulsification extraction and posterior chamber iol implantation have been planned; 2. preoperative corneal astigmatism of one diopter or more in the operative eye; 3. potential for postoperative best corrected distance visual acuity (bcdva) of 20/30 snellen or better; 4. clear intraocular media other than cataract in each eye; 5. ability to understand, read and write english in order to consent to study participation; 6. availability, willingness, sufficient cognitive awareness to comply with examination procedures; 7. signed informed consent document (icd) and health insurance portability and accountability act (hipaa) authorization. exclusion criteria: 1. recurrent severe anterior or posterior segment inflammation or uveitis; 2. compromised eye due to previous trauma or developmental defects in which appropriate support of the iol is not possible; 3. circumstances that would result in damage to the endothelium during implantation; 4. suspected ocular microbial infection; 5. subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to iol decentration, including pseudoexfoliation, trauma, or posterior capsule defects; 6. known ocular disease or pathology that, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the course of the study, \[macular degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, concomitant severe eye disease, extremely shallow anterior chamber, microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.\]; 7. planned monovision correction; 8. concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.
effects of transcranial direct current stimulation on postural control

Conditions: Parkinson Disease

Summary: parkinson's disease is a progressive, degenerative neurological disease associated with profound changes in the quality of life of its survivors. recent evidence has demonstrated the potential use of transcranial direct current stimulation (tdcs) to modulate cerebral excitability and movement control in neurological chronic conditions. however, few studies have investigated the effects of tdcs on postural control in patients with parkinson's disease. this study aims to investigate the effect of bihemispheric tdcs on postural control in people with parkinson's disease. participants will be randomized to receive a single session of anodal and sham bihemispheric tdcs (7 days between each type of stimulation). primary clinical outcome (balance) will be collected before and immediately after tdcs. the data will be collected by a blind examiner to the treatment allocation.


Eligibility criteria:
inclusion criteria: medical diagnosis of idiopathic parkinson's disease present for at least 12 months in clinical follow-up and pharmacological treatment by a responsible physician parkinson's classification of 1.5-3 according to the hoehn and yahr scale signing of the free and informed consent form- exclusion criteria: use any associated orthopedic device to aid gait or balance control signs of severe dementia (evaluated by the mini-mental state examination - mmse) diagnosis of other neurological disorders (including those of central and peripheral nature) previous treatment with tdcs medical diagnosis of psychiatric illnesses with the use of centrally acting medications (depressants) the use of pacemakers or other implanted devices.-
effect of age and device on delivery of fluticasone

Conditions: Asthma

Summary: to determine the effect of age and device on delivery of hfa-fluticasone propionate (fp) in children of different ages. hypothesis -- passive inhalation in younger children through a valved holding chamber/mask (vhc) will reduce the relative amount of fp delivered to airways.

the objective was to determine the effect of age and device on delivery of fluticasone propionate delivered by hfa-pmdi in children of different ages. the one-hour steady-state fluticasone plasma concentration which is an indirect measure of airway delivery and direct measure of systemic exposure, was determined. sixty children with well-controlled persistent asthma received two actuations of 110 mcg twice daily for at least 3 days. a blood sample was collected one hour after the last dose when 100% adherence was documented by electronic monitor. five groups of 12 each were studied: 1) 12-18 yr by actuator alone; 2) 5-9 yr by actuator alone; 3) 5-9 yr by antistatic vhc/mouthpiece; 4) 5-9 yr by antistatic vhc/mask and 5) 1-4 yr by antistatic vhc/mask. fluticasone concentrations were measured by lc-ms/ms assay. fluticasone plasma concentration between groups was compared using one way anova.

Eligibility criteria:
inclusion criteria:children 1-18 yr, adequately controlled persistent asthma, demonstrate effective administration technique in accordance with the group assigned - exclusion criteria:inadequately controlled asthma: nocturnal awakening \>2 nights/month, prn albuterol use \>2x/week, more than 2 short courses of oral corticosteroids in previous 3 months, missing a dose on more than one occasion, increase in asthma symptoms during study, inability to discontinue intranasal or dermal fluticasone for 3 days -

Keywords: fluticasone asthma therapy spacer inhaler hfa-134a
impact of surfactant's availability on newborns

Conditions: Lung Diseases; Respiratory Distress Syndrome

Summary: to identify what happened to specific groups of newborns after surfactant was introduced to the market. were the same benefits with regard to morbidity, mortality, and resource use in evidence post treatment investigational new drug (ind)?

background: the clinical trial literature on surfactant clearly demonstrated that surfactant therapy resulted in improved early respiratory status and improved mortality rates for premature newborns infants suffering from respiratory ailments due to surfactant insufficiency. however, the clinical trial experience regarding efficacy did not ensure that the same benefits would be conferred on patients outside the clinical trial environment during routine medical care. design narrative: the investigators had already demonstrated in an epidemiological study published in the new england journal of medicine (may 1994) that morbidity, mortality, and resource use among very low birth weight inborn infants declined once surfactant became available. this study broadened the focus to include infants excluded from the original study. the hypotheses for the study centered on the investigators' belief that infants who were in the 1500 to 2500 gram weight group also experienced reduced mortality, morbidity, and resource use post-surfactant, as did those who were mature with severe respiratory disease, and those who were outborn i.e. those who were transferred to a perinatal center. finally, because of the significant focus on health care reform and quality assurance in clinical care the investigators included a hypothesis focusing on the impact of payer on mortality, morbidity, and resource use. the original study identified that the payer was not a factor differentiating the newborns with regard to any measures of outcome or resource use. the investigators hypothesized that this would remain the case. however, they suspected that there might be some indications in their analysis among patients who were outborn that hmo or managed care was influencing not only where births were occurring, but how well fragile newborns did in the clinical environment. all the analyses used analytic datafiles from the national perinatal information center's perinatal center database. a pre-and post-surfactant period was created using eleven perinatal centers who provided data on all newborns from 1985 and 1992. infants were divided into two groups according to whether they were born before or after surfactant was introduced into clinical practice. regression models controlling for race, sex, and birthweight were used to assess morbidity, mortality, and resource use. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
a prospective and randomized controlled evaluation of sexual health education program of gynecological cancer women

Conditions: Sexual Health

Summary: the purpose of this study was to evaluate the effectiveness of the gender-sensitive -sexual health education program (gs-shep) in enhancing the sexual health of patients with gynecologic cancer.

this study recruited patients with cervical cancer from the gynecological wards of a large-scale medical center in northern taiwan. a total of 63 participants were divided into two groups. the control group (n=30) received routine sexual health teaching (a 10-15-minute routine individual sexual health education and a sexual health pamphlet without a gender-sensitive and theoretically based design. the experimental group (n=33) received the gs-shep (a 10-15-minute individual sexual health education and a sexual health pamphlet). gs-shep effectiveness was examined using a self-report instrument to measure background information and three dependent variables: "sexual knowledge," "sexual attitudes," "sexual self-efficacy", and "sexual activity". data were collected at baseline, one week, six weeks, four months, and seven months after intervention and analyzed using the statistical software spss 20.0.

Eligibility criteria:
inclusion criteria: 1. women were recruited to participant if they were just been diagnosis with cervical cancertment within the previous 1 weeks. 2. 20 to 80 years old. 3. able to read, write, and speak chinese. 4. in order to comply with the spirit of gender sensitivity in this study, participants do not exclude whether they have a partner or different sexual orientation. exclusion criteria: 1. presence of other malignant disease. 2. impaired mental function. 3. sexual dysfunction (pre-existing sexual dysfunction may confound the impact of cancer treatment on sexual activity). 4. history of female genital organ surgery before diagnosis of gynecological cancer, or a dependent functional status.

Keywords: sexual self-efficacy sexuality health education gender sensitivity transtheoretical model
efficacy study of tln-232 in patients with recurring metastatic melanoma

Conditions: Melanoma

Summary: the objective of this study is to assess the efficacy and safety of tln-232 used to treat patients with metastatic melanoma that recur/progress after receiving first line systemic therapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed stage iv (m1a, m1b, and m1c) unresectable metastatic melanoma (cutaneous, mucosal or acral lentiginous) * first progression after treatment by one first line systemic therapy for metastatic melanoma (immunotherapy or targeted therapy or chemotherapy or any combination of them) * measurable recurrent/progressive disease by radiological scan ≤ 21 days prior to day 1, cycle 1 * age ≥ 18 years * ecog ≤ 2 * normal organ and marrow function as defined below: * leukocytes ≥2.5 x 109/l * absolute neutrophil count ≥1.5 x 109/l * platelets ≥100 x 109/l * hemoglobin ≥100 g/l (10g/dl) * total bilirubin ≤1.5 x institutional uln * ast(sgot)/alt(sgpt) ≤2.5 x institutional uln * creatinine ≤1.5 x institutional uln exclusion criteria: * patients with a life expectancy ≤ 16 weeks * patients with ocular melanoma * patients with symptomatic and/or unstable brain metastasis during the last 3 months (90 days) prior to day 1, cycle 1 * patients with a history of allergic reactions or hypersensitivity to somatostatin analogues * patients with a documented history of hiv, active hepatitis b or c infection * female patients who are pregnant or lactating * patients who are receiving hormonal therapy (with the exception of hormone replacement therapy and hormonal contraceptives), systemic steroids, immunosuppressive therapy or coumadin (low molecular weight heparin is permitted) * patients with grade ≥2 peripheral neuropathy (ctcae criteria) * patients in whom a proper central line cannot be established

Keywords: melanoma metastatic melanoma phase ii skin cancer
a study of tmc435 plus pegylated interferon alfa-2a and ribavirin in participants with chronic hcv infection

Conditions: Hepatitis C, Chronic; Infection

Summary: the purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks of treatment with tmc435 plus pegylated interferon alfa-2a (pegifnα-2a) and ribavirin (rbv) in previously untreated adult participants with genotype 1 or genotype 4 chronic hepatitis c virus (hcv) infection.

this is a multicenter, international study where all participants will receive triple therapy with the following 3 medications: tmc435 also referred to as simeprevir (formerly known as tmc435350) which is an investigational medication in development for the treatment of chronic hepatitis c virus (hcv) infection, pegylated interferon alfa-2a (pegifnα-2a), and ribavirin (rbv). pegifnα-2a and rbv are commercially available therapies for hcv infection. participants will receive treatment with tmc435, pegifnα-2a, and rbv for 12 weeks. if blood levels of hcv ribonucleic acid (rna) monitored at weeks 2, 4, and 8 are below 25 iu/ml, all treatment will be stopped at week 12. if hcv rna values are above 25 iu/ml at weeks 2, 4, or 8, treatment with pegifnα-2a and rbv will continue for an additional 12 weeks (up to week 24) unless protocol-specified stopping criteria are met at week 4 or 12, at which time all treatment will be discontinued. the study will be conducted in 3 phases: a screening phase of maximum 6 weeks, a treatment phase extending from day 1 (baseline) up to 12 or 24 weeks depending on the response to treatment, and a posttreatment follow-up period of 24 weeks after the participant's last planned dose of study drug. the duration of the participation (excluding screening phase) for each participant will vary between 36 and 48 weeks, depending on the response to treatment. blood samples for laboratory analysis will be obtained from participants at protocol-specified time points during the study and participant safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * treatment-naïve with confirmed chronic hepatitis c virus (hcv) infection * liver biopsy performed within 2 years prior to screening or non-invasive confirmation of the liver disease stage (by transient elastography) performed within 6 months prior to screening * liver disease stage equivalent to metavir score f0-f2 (no fibrosis, or portal fibrosis without or with few septa) exclusion criteria: -participants with advanced liver disease equivalent to metavir score f3-f4 (bridging fibrosis or cirrhosis), with hepatic decompensation, with any liver disease of non-hcv etiology, and/or with a non-genotype 1 or non-genotype 4 hepatitis c, hepatitis b or hiv co-infection will be excluded from the study

Keywords: hepatitis c, chronic infection triple therapy tmc435 simeprevir pegylated interferon alfa-2a (pegifnα-2a) ribavirin (rbv) pegasys copegus
assessment of retinal fundus imaging camera

Conditions: Diabetic Retinopathy; Diabetic Macular Edema

Summary: the goal of this prospective study is to evaluate device performance when using fundus images taken from retinal fundus cameras in subjects with and without diabetic retinopathy per etdrs level 35 and higher with or without macular edema.

the goal of this prospective study is to evaluate device performance when using fundus images taken from retinal fundus cameras in subjects with and without diabetic retinopathy (etdrs level 35 and higher) with or without macular edema. study subjects will sign the informed consent form, and data collection will involve being imaged by cameras.

Eligibility criteria:
inclusion criteria: * 22 years of age or older. * documented diagnosis of diabetes mellitus, as per any of the following: having met the criteria established by the world health organization (who) and/or the american diabetes association (ada), hemoglobin a1c (hba1c) ≥ 6.5%, fasting plasma glucose (fpg) ≥ 126 mg/dl (7.0 mmol/l), oral glucose tolerance test (ogtt) with two-hour plasma glucose (2-hr pg) ≥ 200 mg/dl (11.1 mmol/l), using the equivalent of an oral 75g anhydrous glucose dose dissolved in water, symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (rpg) ≥ 200 mg/dl (11.1 mmol/l) * ability to understand and the willingness to sign a written informed consent document. * diagnosis from a retinal specialist of etdrs level of 35 or higher with or without dme or diagnosis from a retinal specialist of etdrs level 20 or lower and no dme. * standard corrected visual acuity of at least 20/40 or better in both eyes. exclusion criteria: * currently participating in an interventional eye study (e.g., actively receiving the investigational product for diabetic retinopathy (dr) and/or diabetic macular edema (dme)). * has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia, or previous enucleation). * pregnancy * has a known allergy to or contraindication for the use of tropicamide 1% or other mydriatic eye drops. * any condition that is contraindicated for the use of study devices in the opinion of the investigator. * contraindication for imaging by devices used in the study due to any of the following: * subject is hypersensitive to light * subject recently underwent photodynamic therapy (pdt) * subject is taking medication that causes photosensitivity
to study generic clindamycin 1%/benzoyl peroxide 5% topical gel (glenmark generics, ltd) in the treatment of acne vulgaris.

Conditions: Acne Vulgaris

Summary: this is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic clindamycin 1%/ benzoyl peroxide 5% topical gel (glenmark generics, ltd), and the marketed product benzaclin® topical gel, clindamycin 1%/ benzoyl peroxide 5% (valeant pharmaceuticals, us) in the treatment of acne vulgaris.


Eligibility criteria:
inclusion criteria: 1. male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris. 2. have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an iga score of 2, 3 or 4. exclusion criteria: 1. subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis. 2. subject has active cystic acne. 3. subject has acne conglobata. 4. subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
valence: valsartan versus atenolol on exercise capacity in hypertensive overweight postmenopausal women

Conditions: Hypertension

Summary: the purpose of the study is to show that valsartan compared to atenolol has favorable effects on exercise capacity, quality of life, diastolic function and elevated blood pressure in hypertensive postmenopausal overweight women with impaired exercise tolerance despite normal left ventricular ejection fraction (lvef).


Eligibility criteria:
inclusion criteria: * body mass index (bmi) must be ≥ 27 and \< 35 * symptoms of impaired exercise capacity (e.g. who report shortness of breath on exertion when questioned) reported at visit 1 or patients who have a history of shortness of breath which improved under diuretic therapy * lv ejection fraction must be \> 45% measured by echocardiography at visit 2. * impaired exercise capacity measured by vo2max at visit 4: vo2max \>14 and \< 22 ml ⋅kg-1 ⋅min-1 exclusion criteria: * mean sitting diastolic blood pressure (msdbp) ≥ 110 mmhg and/or mean sitting systolic blood pressure (mssbp) ≥ 180 mmhg * lvef ≤ 45 % * inability to completely discontinue all previous antihypertensive medications safely for the duration of the study * heavy smokers (\>20 cigarettes/day)

Keywords: postmenopausal women overweight hypertension impaired exercise capacity valsartan atenolol hydrochlorothiazide
a phase i study to study the pk and safety of single doses of sts101, dhe injection and nasal spray in healthy subjects

Conditions: Migraine With Aura; Migraine Without Aura; Migraine

Summary: single-center, single-dose, open-label, 2-part, 3-period crossover (in each part), pharmacokinetic and safety study.

phase 1, open-label, 2-part, single-dose pharmacokinetic and safety study of sts101 in healthy subjects. part 1 was designed to identify a dose level of sts101 for administration in part 2. subjects in part 1 received 3 ascending doses of sts101 in a 3-period crossover manner. during part 2, subjects received the dose of sts101 selected from part 1, 1.0 mg dhe mesylate im injection, and 2 mg dhe mesylate nasal spray in a randomized, 3 period crossover manner.

Eligibility criteria:
inclusion criteria: * 18 to 50 years of age at the time of enrollment. * signed the informed consent document. * subject judged to be healthy by a qualified physician exclusion criteria: * abnormal physical findings of clinical significance at the screening examination * significant abnormal laboratory values at the screening visit. * clinically significant symptoms or conditions that may have placed the subject at an unacceptable risk as a participant in the trial, or that may have interfered with the absorption, distribution, metabolism or excretion of the imp.

Keywords: dihydroergotamine dihydroergotamine mesylate migraine